NXO · Class II · 21 CFR 866.5180

FDA Product Code NXO: Calprotectin, Fecal

The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And Ulcerative Colitis And To Differentiate Ibd From Irritable Bowel Syndrome.

Leading manufacturers include Eurospital S.P.A., Buhlmann Laboratories AG and Inova Diagnostics, Inc..

15
Total
14
Cleared
157d
Avg days
2006
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Calprotectin, Fecal Devices (Product Code NXO)

15 devices
1–15 of 15
Cleared Feb 06, 2024
BÜHLMANN fCAL® turbo and CALEX® Cap
K232057
B?hlmann Laboratories AG
Immunology · 210d
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763
ALPCO
Immunology · 393d
Cleared Jul 26, 2022
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858
DiaSorin, Inc.
Immunology · 228d
Cleared Oct 25, 2019
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807
ALPCO
Immunology · 112d
Cleared Sep 24, 2019
Buhlmann fCAL turbo and CALEX Cap
K191718
Buhlmann Laboratories AG
Immunology · 90d
Cleared Jul 10, 2019
Calprest, EasyCal
K191589
Eurospital S.P.A.
Immunology · 26d
Cleared Jul 10, 2019
CalprestNG, EasyCal
K191592
Eurospital S.P.A.
Immunology · 26d
Cleared Jun 25, 2019
BUHLMANN fCAL turbo
K190784
Buhlmann Laboratories AG
Immunology · 90d
Cleared Dec 26, 2018
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
K182698
DiaSorin, Inc.
Immunology · 90d
Cleared Oct 16, 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971
Inova Diagnostics, Inc.
Immunology · 186d
Cleared Jun 04, 2018
BUHLMANN fCAL ELISA
K181012
Buhlmann Laboratories AG
Immunology · 48d
Cleared Dec 22, 2017
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
K170993
Inova Diagnostics, Inc.
Immunology · 263d
Cleared Nov 10, 2016
Calprest NG
K160447
Eurospital S.P.A.
Immunology · 267d
Cleared Jan 16, 2014
CALPREST
K130945
Eurospital S.P.A.
Immunology · 287d
Not Cleared Apr 26, 2006
PHICAL TEST
DEN060001
Genova Diagnostics
Immunology · 34d

About Product Code NXO - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code NXO since 2006, with 14 receiving FDA clearance (average review time: 157 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.